Associate Director, Biologics CMC, Drug Product

Role Overview

• Develop biologics drug product formulations, processes, and administration/delivery methods throughout program’s lifecycle (preclinical through commercialization).
• Contribute to and manage biologics drug product process technical transfer to CMOs and provide oversight during manufacturing.
• Develop and manage external drug product development and manufacturing capabilities and network.
• Ensure compliance with FDA, cGMPs, and ICH guidelines.
• Author and review technical documents and regulatory filings; support associated agency interactions and product-related inspections.
• Support development and implementation of new process technologies to meet business and portfolio needs.
• Remain current on trends and new technology advancements across the biopharmaceutical industry.

Requirements

• Ph.D. or Master’s degree in Pharmaceutical Sciences, Chemical Engineering or relevant field.
• Minimum 8+ years of relevant experience in biotech/pharma industry, with a focus on drug product development and manufacturing for therapeutic protein products.
• Extensive hands‐on experience and in-depth knowledge and understanding of protein formulation development, fill-finish process engineering, and administration/delivery, with working knowledge of non-monoclonal antibody formats.
• Proven ability to manage global, external vendors for development, manufacturing, and testing is essential.
• Proven experience in the generation of CMC regulatory sections of IND, IMPD, BLA, and MAA filings. Extensive familiarity with phase-appropriate cGMP requirements and FDA, EU, and ICH guidelines.
• Previous success working effectively in a multidisciplinary, highly matrixed environment with ability to collaborate and drive for results.
• Excellent decision-making, written and verbal communication skills.
• Motivated self-starter with excellent interpersonal and organizational skills. Strong self-awareness of the impact communication and working style has on others.
• Qualities of the successful candidate include the following: collaboration, accountability, cross-functional engagement, and program management.

Benefits

• annual bonus opportunity (20% of salary)
• annual equity awards
• medical, dental, vision, life and disability insurance
• 401(K) plan with employer match
• stock options
• employee stock purchase plan
• flexible non-accrual paid time off
• paid holidays
• end-of-year shut down
• cell phone reimbursement
• tuition reimbursement
• paid parental leave